Marketing
Service / Grading and Verification Division
13952 Denver West Parkway, Suite 350
Lakewood, CO 80401 / GVD 1012AA Checklist
June 18, 2013
Page 3 of 58
USDA ISO 17065 Program Checklist
This checklist is for referencing the client's documentation to program criteria.
· New clients must submit a completed checklist in the application for service. (Refer to GVD 1000 Procedure and GVD 1012 Procedure.)
· Accredited client are asked to update the checklist prior to any surveillance assessments and reassessments.
Date:Name of Company :
Est. No.:
Company Address:
City, State, Zip:
Contact Name:
Title:
Phone #:
Email:
Location(s) of Program Activities:
Standards Applied:
Scope of Program Activities:
Table of Contents
4 General Requirements
4.1 Legal and Contractual Matters
4.1.1 Legal Responsibility
/4.1.1
/ /4.1.2 Certificate Agreement
/4.1.2
/4.1.2.1
/4.1.2.2
4.1.3 Use of License, Certificates, and Marks of Conformity
/4.1.3.1
/4.1.3.2
/4.2 Management of Impartiality
4.2.1
/4.2.2
/4.2.3
/4.2.4
4.2.5
/4.2.6
/4.2.7
/4.2.8
4.2.9
/4.2.10
/4.2.11
/4.2.12
4.3 Liability and Financing
/4.3.1
/4.3.2
/4.4 Non-discriminatory Conditions
/4.4.1
/4.4.2
/4.4.3
4.4.4
/ / /4.5 Confidentiality
/4.5.1
/4.5.2
/4.5.3
4.6 Publicly Available Information
4.6
/4.6(a)
/4.6(b)
/4.6(c)
4.6(d)
/ / /5 Structural Requirements
5.1 Organizational Structure and Top Management
/5.1.1
/5.1.2
/5.1.3
/ /5.1.4
/5.2 Mechanism for Safeguarding Impartiality
5.2.1
/5.2.2
/5.2.3
/5.2.4
6 Resource Requirements
6.1 Certification Body Personnel
6.1.1 General
6.1.1
/6.1.1.1
/6.1.1.2
/6.1.1.3
6.1.2 Management of Competence for Personnel Involved in the Certification Process
6.1.2
/6.1.2.1
/6.1.2.2
/6.1.3 Contract With The Personnel
6.1.3
/ / /6.2 Resources for Evaluation
6.2.1 Internal Resources
6.2.1
/ / /6.2.2 External Resources (Outsourcing)
6.2.2
/6.2.2.1
/6.2.2.2
/6.2.2.3
6.2.2.4
/ / /7 Process Requirements
7.1 General
7.1
/7.1.1
/7.1.2
/7.1.3
7.2 Application
7.2
/ / /7.3 Application Review
7.3
/7.3.1
/7.3.2
/7.3.3
/7.3.4
/7.3.5
/7.4 Evaluation
7.4
/7.4.1
/7.4.2
/7.4.3
7.4.4
/7.4.5
/7.4.6
/7.4.7
7.4.8
/7.4.9
/ /7.5 Review
7.5
/7.5.1
/7.5.2
/7.6 Certification Decision
7.6
/7.6.1
/7.6.2
/7.6.3
7.6.4
/7.6.5
/7.6.6
/7.7 Certification Documentation
7.7
/7.7.1
/7.7.2
/7.7.3
7.8 Directory of Certification Products
7.8
/ / /7.9 Surveillance
7.9.1
/7.9.2
/7.9.3
/7.9.4
7.10 Changes Affecting Certification
/7.10.1
/7.10.2
/7.10.3
7.11 Termination Reduction Suspension or Withdrawal of Certification
/7.11.1
/7.11.2
/7.11.3
7.11.4
/7.11.5
/7.11.6
/7.12 Records
/7.12.1
/7.12.2
/7.12.3
7.13 Complaints and Appeals
/7.13.1
/7.13.2
/7.13.3
7.13.4
/7.13.5
/7.13.6
/7.13.7
7.13.8
/7.13.9
/ /8 Management System Requirements
8.1 Options
8.1.1 General
/8.1.2 Option A
/8.1.3 Option B
/8.2 General Management System Documentation (Option A)
/8.2.1
/8.2.2
/8.2.3
8.2.4
/8.2.5
/ /8.3 Control of Documents (Option A)
8.3
/8.3.1
/8.3.2
/8.4 Control of Records (Option A)
8.4
/8.4.1
/8.4.2
/8.5 Management Review (Option A)
8.5.1 General
/8.5.1.1
/8.5.1.2
/8.5.2 Review Inputs
8.5.2
/ / /8.5.3 Review of Outputs
8.5.3
/ /8.6 Internal Audits (Option A)
/8.6.1
/ 8.6.2 /8.6.3
8.6.4
/ /8.7 Corrective Actions (Option A)
8.7.1
/8.7.2
/ 8.7.3 /8.7.4
8.8 Preventative Actions (Option A)
/8.8.1
/ 8.8.2 /8.8.3
PROGRAM REQUIREMENTS
· Section (1) is to be completed by the client. Identify certification program documents and sections that address each criterion.
· Section (2) is to be completed by the audit team.
· Section (3) is to be completed by the audit team. Explanations and/or comments must be provided to provide evidence of conformance or non-conformance, as applicable.
ISO/IEC 17065 / Client's ReferenceDocument (1) / Conforms (2) / Remarks (3) /
Yes / No /
4 General Requirements
4.1 Legal and Contractual Matters
4.1.1 Legal responsibilityThe certification body shall be a legal entity, or a defined part of a legal entity, such that the legal entity can be held legally responsible for all its certification activities.
NOTE: A governmental certification body is deemed to be a legal entity on the basis of its governmental status.
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4.1.2 Certification agreement
Table of Contents Also see 7.2, 7.7.3(c)
4.1.2.1 The certification body shall have a legally enforceable agreement for the provision of certification activities to its clients. Certification agreements shall take into account the responsibilities of the certification body and its clients.
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4.1.2.2 The certification body shall ensure its certification agreement requires that the client comply at least, with the following:
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a) the client always fulfills the
certification requirements (see 3.7), including implementing appropriate changes when they are communicated by the certification body (see 7.10);
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b) if the certification applies to ongoing
production, the certified product continues to fulfill the product requirements (see 3.8);
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c) the client makes all necessary
arrangements for:
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1) the conduct of the evaluation (see
3.3) and surveillance (if required), including
provision for examining documentation and records, and access to the relevant equipment, location(s), area(s), personnel, and client's subcontractors;
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2) investigation of complaints;
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3) the participation of observers, if
applicable;
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d) the client makes claims regarding
certification consistent with the scope of certification (see 3.10);
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e) the client does not use its product
certification in such a manner as to bring the certification body into disrepute and does not make any statement regarding its product certification that the certification body may consider misleading or unauthorized;
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f) upon suspension, withdrawal, or
termination of certification, the client discontinues its use of all advertising matter that contains any reference thereto and takes action as required by the certification scheme (e.g. the return of certification documents) and takes any other required measure;
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g) if the client provides copies of the
certification documents to others, the documents shall be reproduced in their entirety or as specified in the certification scheme;
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h) in making reference to its product
certification in communication media such as documents, brochures or advertising, the client complies with the requirements of the certification body or as specified by the certification scheme;
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i) the client complies with any
requirements that may be prescribed in the certification scheme relating to the use of marks of conformity, and on information related to the product;
NOTE: See also ISO/IEC 17030, ISO/IEC Guide 23 and ISO Guide 27.
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j) the client keeps a record of all
complaints made known to it relating to compliance with certification requirements and makes these records available to the certification body when requested, and
NOTE: Verification of item j) by the certification body can be specified in the certification scheme.
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1) takes appropriate action with respect to
such complaints and any deficiencies found in products that affect compliance with the requirements for certification;
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2) documents the actions taken;
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k) the client informs the certification body, without delay, of changes that may affect its ability to conform with the certification requirements.
NOTE Examples of changes can include the following:
---the legal, commercial, organizational status or ownership,
---organization and management (e.g. key managerial, decision-making or technical staff),
---modifications to the product or the production method,
---contact address and production sites,
---major changes to the quality management system.
4.1.3 Use of License, Certificates, and Marks of Conformity
4.1.3.1 The certification body shall exercise
the control as specified by the certification
scheme over ownership, use and display of
licenses, certificates, marks of conformity, and
any other mechanisms for indicating a product
is certified.
NOTE 1 Guidance on the use of certificates
and marks permitted by the certification body can be
obtained from ISO/IEC Guide 23.
NOTE 2 ISO/IEC 17030 provides requirements for the
use of third-party marks.
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4.1.3.2 Incorrect references to the certification scheme, or misleading use of licenses, certificates, marks, or any other mechanism for indicating a product is certified, found in documentation or other publicity, shall be dealt with by suitable action.
NOTE Such actions are addressed in ISO Guide 27 and can include corrective actions, withdrawal of certificate, publication of the transgression and, if necessary, legal action.
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4.2 Management of impartiality
4.2.1 Certification activities shall be undertaken impartially.
Table of Contents Also see 6.1.3(c)
4.2.2 The certification body shall be responsible for the impartiality of its certification activities and shall not allow commercial, financial or other pressures to compromise impartiality
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4.2.3 The certification body shall identify risks to its impartiality on an ongoing basis. This shall include those risks that arise from its activities, from its relationships, or from
the relationships of its personnel (see 4.2.12). However, such relationships may not necessarily present a certification body with a risk to impartiality.
NOTE: 1 A relationship presenting a risk to impartiality of the certification body can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement forth referral of new clients, etc.
Also see 4.2.7
NOTE: 2 Identifying risks does not imply risk
assessments as stated in ISO 31000.
Table of Contents Also see 6.1.3
4.2.4 If a risk to impartiality is identified, the certification body shall be able to demonstrate how it eliminates or minimizes such risk. This information shall be made available to the mechanism specified in 5.2.
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4.2.5 The certification body shall have top management commitment to impartiality.
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4.2.6 The certification body and any part of the same legal entity and entities under its organizational control (see 7.6.4) shall not:
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a) be the designer, manufacturer, installer,
distributer or maintainer of the certified product;
b) be the designer, implementer, operator
or maintainer of the certified process;
c) be the designer, implementer, provider or maintainer of the certified service;
d) offer or provide consultancy (see 3.2) to its clients;
e) offer or provide management system consultancy or internal auditing to its clients where the certification scheme requires the evaluation of the client’s management system.
NOTE 1 This does not preclude the following:
-- the possibility of exchange of information (e.g. explanations of findings or clarifying requirements) between the certification body and its clients;
--- the use, installing and maintaining of certified products which are necessary for the operations of the certification body.
NOTE 2 “Management system consultancy” is defined in ISO/IEC 17021:2011, definition 3.3.
4.2.7 The certification body shall ensure that activities of separate legal entities, with which the certification body or the legal entity of which it forms a part has relationships, do not compromise the impartiality of its certification activities.
NOTE See 4.2.3, Note 1.
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4.2.8 When the separate legal entity in 4.2.7 offers or produces the certified product (including products to be certified) or offers or provides consultancy (see 3.2), the certification body's management personnel and personnel in the review and certification decision-making process shall not be involved in the activities of the separate legal entity. The personnel of the separate legal entity shall not be involved in the management of the certification body, the review, or the certification decision.
NOTE: For the evaluation personnel, impartiality requirements are stipulated in Clause 6 and additional requirements are given in the other relevant International Standards cited in 6.2.1 and 6.2.2.1.
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4.2.9 The certification body's activities shall not be marketed or offered as linked with the activities of an organization that provides consultancy (see 3.2). A certification body shall not state or imply that certification would be simpler, easier, faster or less expensive if a specified consultancy organization were used.
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4.2.10 Within a period specified by the certification body, personnel shall not be used to review or make a certification decision for a product for which they have provided consultancy (see 3.2).
NOTE 1 The period can be specified in the certification scheme or, if specified by the certification body, it reflects a period that is long enough to ensure that the review or decision does not compromise impartiality. A specified period of two years is often used.
NOTE 2 For the evaluation personnel, impartiality requirements are stipulated in Clause 6 and additional requirements are given in the other relevant International Standards cited in 6.2.1 and 6.2.2.1.
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4.2.11 The certification body shall take action to respond to any risks to its impartiality, arising from the actions of other persons, bodies or organizations, of which it becomes aware.
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4.2.12 All certification body personnel (either internal or external) or committees who could influence the certification activities shall act impartially.
Table of Contents Also see 4.2.3
4.3 Liability and financing
4.3.1 The certification body shall have adequate arrangements (e.g. insurance or reserves) to cover liabilities arising from its operations.
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4.3.2 The certification body shall have the financial stability and resources required for its operations.
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4.4 Non-discriminatory conditions
4.4.1 The policies and procedures under which the certification body operates, and the administration of them, shall be non-discriminatory. Procedures shall not be used to impede or inhibit access by applicants, other than as provided for in this International Standard.
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